Optetrak 208-04-44Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862053428), received between Dec 30, 2024 and Dec 30, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

34 other recalls cover devices cleared under the same FDA submission (K023186); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 81 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, PAIN, SYNOVITIS, BONE FRACTURE(S). REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Pain; Synovitis

  MAUDE report 21035801 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023186. One submission often covers many models, so check the product and lot details in each record.

• Z-0131-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.
• Z-0136-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX.
• Z-0145-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.
• Z-0157-2018 · Sep 19, 2017 · Terminated
  Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX.
• Z-0156-2018 · Sep 19, 2017 · Terminated
  Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.
• Z-0128-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.
• Z-0150-2018 · Sep 19, 2017 · Terminated
  Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX.
• Z-0154-2018 · Sep 19, 2017 · Terminated
  Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.
• Z-0152-2018 · Sep 19, 2017 · Terminated
  Optetrak Constrained Condylar Offset Screw, Size HH, Ref 208-04-76, Sterile, RX.
• Z-0132-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.
• Z-0129-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.
• Z-0135-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.
• Z-0142-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.
• Z-0126-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX.
• Z-0159-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX.

…and 19 more.